Global Site Activation Analyst
Buenos Aires, AR
hace 22 horas
source : DirectEmployers Association

The Global Site Activation Analyst role would provide an opportunity for selected candidates to enhance their knowledge(Site-Id to Close-out activities) & skills(Analytics, Project Management etc.

This role would partner with SAM & work closely with Maintenance Leads, Site-Id leads, Study Team members etc. on various tasks. Essential Functions :

  • Under general supervision, serve as Single Point of Contact (SPOC) in assigned studies for investigative sites, Site Activation Manager (SAM), Project Management team, and other departments as necessary.
  • Ensure adherence to standard operating procedures (SOPs), Work Instructions (WIs), quality of designated deliverables and project timelines.

  • Perform start up and site activation activities according to applicable regulations, SOPs and work instructions. Distribute completed documents to sites and internal project team members.
  • Prepare site regulatory documents, reviewing for completeness and accuracy.
  • Ensure accurate completion and maintenance of internal systems, databases and tracking tools with project specific information.
  • Review and provide feedback to management on site performance metrics.
  • Review, establish and agree on project planning and project timelines. Ensure monitoring measures are in place and implement contingency plan as needed.
  • Inform team members of completion of regulatory and contractual documents for individual sites.
  • Review, track and follow up the progress, the approval and execution of documents, regulatory, ethics, Informed Consent Form (ICF), and Investigator Pack (IP) release documents, in line with project timelines.
  • Provide local expertise to SAMs and project team during initial and on-going project timeline planning.
  • Perform quality control of documents provided by sites.
  • May have direct contact with sponsors on specific initiatives. Qualifications :
  • Bachelor s degree in Life Science or related field.
  • At least four year of clinical research experience.
  • In-depth knowledge of Clinical trial environment and Drug development process.
  • Good Analytical skills & understanding of reports (Spotfire, CTMS)
  • Good knowledge of various Tools & Systems used during start-up (eg. CTMS, eTMF, Wingspan, Workflow tools (RSU WF / DrugDev etc.
  • RID, Advanced Excel, Word, PPT etc.)

  • Good knowledge of multiple Startup activities(Global & Regional) would be an advantage.
  • Good Communication & Collaboration skills.
  • English Level advanced.
  • Good Planning & Problem solving skills.
  • Ability to manage complex tasks independently.
  • Understanding of SAM roles & responsibilities would be an added advantage.At IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible - to help our customers create a healthier world.
  • The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

    Learn more at IQVIA is a world leader in using data, technology, advanced analytics, and expertise to help customers drive healthcare - and human health - forward.

    Together with the companies we serve, we are enabling a more modern, more effective and more efficient healthcare system, and creating breakthrough solutions that transform business and patient outcomes.

    To get there, it takes diverse skills and a curiosity to explore new possibilities. No matter your role, everyone at IQVIA, including our colleagues at Q² Solutions, contributes to our shared goal of improving human health.

    Thank you for your interest in growing your career with us.EEO Minorities / Females / Protected Veterans / Disabled

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